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BIONEXIA® Rota-Adeno

Aid for rapid, differential diagnosis of viral gastroenteritis

BIONEXIA® Rota-Adeno is a qualitative immunochromatographic test that allows simultaneous detection and differentiation of Rotavirus and Adenovirus in a single stool extract. It offers a doubly simple and doubly reliable solution for rapid diagnosis of viral gastroenteritis.

Differentiating a bacterial gastroenteritis from a viral form is key to ensure appropriate patient management and treatment. Early diagnosis of viral infection by laboratory testing helps avoid unnecessary use of antimicrobial therapy and contain disease outbreaks.

Rotavirus group A and Adenovirus serotypes 40 & 41 are a common cause of viral gastroenteritis, with Rotavirus being the leading cause of acute gastroenteritis in infants and young children. Guidelines for the management of gastroenteritis recommend the use of Rotavirus and Adenovirus antigen tests as a first-line answer for children under the age of 5, immuno-compromised patients and disease outbreaks investigation in institutions1.

The BIONEXIA® Rota-Adeno test allows rapid detection and differentiation of Rotavirus and Adenovirus in human stool specimens, providing an accurate first-line answer in the management of patients presenting with symptoms of gastroenteritis.

Ease of use for rapid results

Validated for use in laboratories and for near-patient testing as part of a medical consultation

State-of-the-art performance

A multi-center study was carried out in 3 clinical laboratories in Europe using stool samples collected from patients showing gastroenteritis symptoms. The results of the BIONEXIA® Rota-Adeno test were compared to those of a real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) test and/or an immunochromatographic test (ICT):

Performance on Rotavirus vs. RT-PCR

Performance on Rotavirus vs. ICT

Performance on Adenovirus vs. ICT

Positive % Agreement

(80/89)89.9%

(80/82)97.6%

(25/31)80.7%

Negative % Agreement

(108/111)97.3%

(117/120)97.5%

(171/171)100%

Performance on Adenovirus:

6 samples that were positive with the other ICT and negative with BIONEXIA® Rota-Adeno were, for 5 of them, Adenovirus serotypes 1, 2, 3, 5 or 21, which are not common causes of gastroenteritis. Adenovirus serotypes 40 and 41 are the most common serotypes responsible for gastroenteritis, whereas other serotypes are responsible for respiratory infections2. The BIONEXIA® Rota-Adeno test is more specific for detection of serotypes 40 and 41 than the other immunochromatographic test used in the evaluation study.

1 sample was not serotyped.

Performance on Rotavirus:

Within the evaluation study presented above, the BIONEXIA® Rota-Adeno test demonstrated 89.9% sensitivity versus RT-PCR. A recent study3 comparing several Rotavirus rapid tests with RT-PCR showed that the best test demonstrated a 78.2% sensitivity. The performances of the BIONEXIA® Rota-Adeno test are therefore excellent.

The performance data of the BIONEXIA® Rota-Adeno test adhere to new European accreditation requirements.